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Understanding Computer System Validation (CSV) Training Course

A comprehensive and practical introduction

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry.

★★★★★ "Overall, the course was really good, the speakers were of a very high standard and knew their stuff ... more (6)"

18-19 March 2025
+ 9-10 July 2025, 24-25 November 2025 »

from £1099

Need help?  Enrol or reserve

Course overview

Computer Systems Validation (CSV) is a process used to test, validate and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable and traceable. The system has to be relied upon to:

  • produce data accurately and consistently
  • create an indelible electronic data trail that is transparent, traceable and tamper-proof
  • store electronic data records in a way that is safe, secure and can stand the test of time

Computerised system validation and compliance is a regulatory requirement. Inadequate or inappropriate validation can lead to serious non-compliance and quality problems. Compliant and validated computer systems are a prerequisite for effective data integrity.

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5).

This course will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of attending

  • Gain a comprehensive overview of computer system validation (CSV)
  • Enhance your understanding of the key terms used in CSV
  • Recognise how Good Practices apply to computerised systems
  • Understand the different approaches which might be employed
  • Learn how to manage the risk associated with data integrity

Who should attend?

  • Quality management specialists
  • Pharmaceutical validation professionals
  • Pharmaceutical project managers
  • Computer system engineering specialists

Enrol or reserve

Paul Palmer
Paul R Palmer Ltd

Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices. 

Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.

People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.

Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

18-19 March 2025

Live online

09:30-17:30 UK (London) (UTC+00)
10:30-18:30 Paris (UTC+01)
05:30-13:30 New York (UTC-04)
Timings may be different for each day
Course code 14602

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 11 Feb

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Not ready to book yet?

for 7 days, no obligation

9-10 July 2025

Live online

09:30-17:30 UK (London) (UTC+01)
10:30-18:30 Paris (UTC+02)
04:30-12:30 New York (UTC-04)
Timings may be different for each day
Course code 14871

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 04 Jun

View basket 

 
Not ready to book yet?

for 7 days, no obligation

24-25 November 2025

Live online

09:30-17:30 UK (London) (UTC+00)
10:30-18:30 Paris (UTC+01)
04:30-12:30 New York (UTC-05)
Timings may be different for each day
Course code 15091

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 20 Oct

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Understanding Computer System Validation (CSV) training course


Overall, the course was really good, the speakers were of a very high standard and knew their stuff super well. This really shone through their examples and diverse experience in pharmaceuticals.

Mar 19 2024

Yasmeen Scotto
QA Validation Associate, Catalent Micron Technologies Limited

Jul 24 2024

Overall the course was good.

Ervin Javier Obnial
Validation Specialist, ViroCell Biologics

Jul 24 2024

Very patient and understanding of everyone's different experience in the industry. Very good course, lots of detail provided, all questions were answered with detail and understanding. I enjoyed the examples provided for the principles (e.g. what went right and what went wrong). Also enjoyed the collaborations with other participants.

Luissana Vidal
Principal Validation Specialist, ViroCell Biologics Ltd

Jul 26 2023

My overall opinion is that this course was very worthwhile and well taught. I feel as though I learned a lot but I have learned in a way in which I will be able to apply this knowledge confidently to my job.

Rachel Power
R&D Project Technician, Teva Pharmaceuticals Europe BV

Jul 26 2023

Paul gave a very informative and interactive course. He made the learning enjoyable, and it was obvious how knowledgeable he was.

Brid Hogan
R&D Project associate, Teva Pharmaceuticals Europe BV

Jul 26 2023

Good, well presented and full of information and knowledge

Iti Sharma
QA Assosiate, Nox Medical

United Kingdom

  • Catalent Micron Technologies Limited
  • PharSafer
  • Revolent
  • ViroCell Biologics
  • ViroCell Biologics Ltd

Iceland

  • Nox Medical

Ireland

  • Teva Pharmaceuticals Europe BV

Netherlands

  • Venn Life Sciences ED B.V.

Norway

  • Gentian AS

Switzerland

  • BSI Business Systems Integration AG

Enrol or reserve

Run Understanding Computer System Validation (CSV) Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy